Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03125902 · OUTCOME

Duration of Objective Response (DOR) Assessed Using RECIST v1.1 in DOR-evaluable Population (Unconfirmed)

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) · Source last updated 2024-03-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From objective response to PD, assessed up to primary completion date (approximately 26 months)

What was measured

DOR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first. CR is defined as the disappearance of all TLs and SA reduction to \<10mm for nodal TLs/ non-TLs. PR is defined as \>/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as \>/=20% relative increase and \>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.

Analysis population: Duration of response (DoR)-evaluable population: participants in the ITT population with measurable disease at baseline

Groups in this outcome

Placebo and Paclitaxel

Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

Atezolizumab and Paclitaxel

Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo and Paclitaxel104
Atezolizumab and Paclitaxel231

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo and Paclitaxel5.45Not reported4.676.31Not reported
Atezolizumab and Paclitaxel6.41Not reported5.557.39Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.02
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified Analysis
    non Inferiority Type
    OTHER
    p Value
    0.0641
    param Type
    Hazard Ratio (HR)
    param Value
    0.74
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.02
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified Analysis
    non Inferiority Type
    OTHER
    p Value
    0.0641
    param Type
    Hazard Ratio (HR)
    param Value
    0.74
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.67
        upper Limit
        6.31
        value
        5.45
      2. group Id
        OG001
        lower Limit
        5.55
        upper Limit
        7.39
        value
        6.41
denoms
  1. counts
    1. group Id
      OG000
      value
      104
    2. group Id
      OG001
      value
      231
    units
    Participants
description
DOR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first. CR is defined as the disappearance of all TLs and SA reduction to \<10mm for nodal TLs/ non-TLs. PR is defined as \>/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as \>/=20% relative increase and \>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Placebo and Paclitaxel
  2. description
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG001
    title
    Atezolizumab and Paclitaxel
param Type
MEDIAN
population Description
Duration of response (DoR)-evaluable population: participants in the ITT population with measurable disease at baseline
reporting Status
POSTED
time Frame
From objective response to PD, assessed up to primary completion date (approximately 26 months)
title
Duration of Objective Response (DOR) Assessed Using RECIST v1.1 in DOR-evaluable Population (Unconfirmed)
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice